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Open, Classified

The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graft and a Straight Iliac Extension Stent-Graft. Each stent-graft is preloaded into its own delivery system that is advanced under fluoroscopy to the location of the infrarenal aneurysm. The stent-graft is deployed at the intended location and creates a blood flow channel, excluding the aneurysm from blood pressure and flow.

FDA Recall Z-1689-2023 · Posted 2023-06-06

Recalling FirmBolton Medical Inc.
Recall StatusOpen, Classified
Product CodeMIH
Date Initiated2023-05-03
Product Quantity216 units

Reason for Recall

Potential for the incorrect size stent-graft than the printed carton label.

Firm Action

Bolton Medical notified consignees via letter delivered through USPS Certified delivery, on 05/03/2023. Consignees were instructed to examine inventory and quarantine any affected units, complete and return the Acknowledgement Form, arrange for the return of affected units, and maintain a copy of the notification for your records.

Root Cause

Process control

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of FL, NY, VA, WA and the countries of Italy, Great Britain, and Switzerland.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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